Parkinson's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Recruit 10 Parkinson's disease patients who meet the clinical diagnostic criteria for Parkinson's disease and are diagnosed according to the UK Brain Bank Parkinson's Disease Diagnostic Criteria or other recognized diagnostic criteria; 2. There are symptoms of constipation that meet the diagnosis of functional constipation in Rome IV criteria, which means that at least 25% of bowel movements feel laborious, at least 25% of bowel movements are dry or hard, at least 25% of bowel movements feel incomplete, at least 25% of bowel movements have a feeling of anorectal obstruction or blockage, at least 25% of bowel movements require manual assistance (such as finger assisted bowel movements, pelvic floor support), and spontaneous bowel movements occur less than 3 times a week; 3. Age between 30-80, gender not limited; 4. The patient or their legal representative is able to understand and sign the informed consent form, voluntarily participate in this study, and follow the study protocol; 5. Participants must adhere to stable Parkinson's disease treatment for 90 days prior to enrollment and throughout the entire study period. During the study, they were not allowed to take unnecessary antibiotics or probiotics.
Exclusion criteria
Exclusion criteria: 1. There are serious immunodeficiency diseases, such as human immunodeficiency virus (HIV) infection, congenital immunodeficiency syndrome, etc., because these patients may not be able to withstand the risk of immune response during fecal microbiota transplantation treatment, and immune dysfunction may affect the colonization of intestinal microbiota and treatment effectiveness; 2. Severe liver and kidney dysfunction (exceeding the normal average by three times). Liver and kidney dysfunction may affect drug metabolism and excretion, increase the risk of adverse reactions during treatment, and may also interfere with the accurate evaluation of the effectiveness of fecal microbiota transplantation therapy; 3. For patients who are unable to provide informed consent, such as those with severe cognitive impairment or mental illness that makes it difficult for them to understand the research content and risks, ensure that patients can independently decide whether to participate in the study and protect their rights and interests; 4. Accompanied with diarrhea, Clostridium difficile infection or other intestinal pathogen infection (determined by stool routine, culture and related tests), these infectious diseases need targeted treatment first, otherwise it may affect the efficacy evaluation of flora transplantation, and flora transplantation may lead to the spread of infection or exacerbation of the disease; 5. History of inflammatory bowel disease, cancer, and gastrointestinal surgery; 6. Have a clear history of organic brain diseases such as traumatic brain injury, cerebral palsy, and encephalitis; 7. There is a record of antibiotic use within the first 6 weeks of inclusion, and participation in other drug trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) score;Wexner Constipation Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini Mental State Examination (MMSE) score;Hamilton Depression Scale score;Hamilton Anxiety Scale score;Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL) score;Pittsburgh Sleep Quality Index Survey Form score; | — |
Countries
China
Contacts
Jinan Central Hospital (Capital Medical University Xuanwu Hospital Jinan Hospital)